Treatment of Periodontal Intraosseous Defects

NCT04542746 | Completed DMC

• 1 other identifier: 0012240
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to evaluate the impact of surgical flap design on the healing of intrabony defects treated by means periodontal regeneration. Forty patients were enrolled and allocated random in two groups. Patients of test group received a minimally invasive surgical flap , while patients of control group received a conventional access flap. In both group the intrabony were treated by means the same periodontal regeneration procedure (i.e application of enamel matrix derivative). Periodontal parameters were recoded at baseline and after 12-months observation time.

Conditions

Periodontal Pocket

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level gain ( CAL gain)

  Vertical measure from the cement enamel junction to the bottom of the defect.

  At 12 months

Study Arms (2)

Minimally invasive surgical technique

EXPERIMENTAL

The intra-bony defects of subjects allocated in test group were treated with a combination of minimally invasive surgical technique (MIST) and enamel matrix derivative( EMD).

Procedure: Minimally invasive surgical technique

Conventional open flap debridement with papilla preservation

ACTIVE COMPARATOR

The intra-bony defects of control group were treated using a combination of conventional open flap debridement with papilla preservation (COFD+PP) and EMD.

Procedure: Minimally invasive surgical technique

Interventions

Minimally invasive surgical technique PROCEDURE

After local anesthesia , for the sites of test group , a minimally invasive surgical technique (MIST) will be performed. The defects associated inter-dental papilla will be surgically approached with a diagonal incision following the pattern of the simplified papilla preservation flap. Flap elevation was to the buccal and oral aspect in the interdental space, An enamel matrix derivative (EMD) was applied into the defect.f A primary closure of the interdental papillae will be achieved using a 5-0 monofilament non resorbable suturing material.

Also known as: Conventional open flap debridement with papilla preservation

Conventional open flap debridement with papilla preservation; Minimally invasive surgical technique

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from chronic periodontitis;
• Male and female ;
• Age 18 years old;
• Presence of intra-bony defects (contained and non-contained defects) in either the maxilla or the mandible with a PD ≥ 6 mm.
• II and III wall Intra-bony defects with an intra-bony component range from 3 mm to 6 mm for both groups;
• Intra-bony defect located only at one aspect ( mesial or distal)

You may not qualify if:

• Patients with systemic disease;
• Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery;
• Pregnant or lactating;
• Tobacco smokers;
• Patients with FMPS and FMBS 25 % after completion of non surgical periodontal therapy (recorded at six sites per tooth);
• Furcations;
• Third molars
• Teeth with circumferencial defects
• I-wall intra-bony defects

Sponsors & Collaborators

• Iorio Research and Dental Practice: lead

Study Sites (1)

Iorio Research and Dental Practice

Naples, 80038, Italy

Location

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS,PhD

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: September 9, 2020
• Study Start: July 28, 2017
• Primary Completion: August 12, 2018
• Study Completion: December 18, 2018
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

IT (1)